Senior Regulatory Specialist (m/f/d) - IVD

TN United Kingdom; Cheadle; Hybrid; GBP 45,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Senior Regulatory Specialist, where you'll play a pivotal role in bringing innovative IVD products to the global market. This dynamic position involves coordinating regulatory submissions, ensuring compliance with international standards, and leading cross-functional projects. With a commitment to quality and safety, you'll have the opportunity to work in a collaborative environment that values diversity and inclusion. The company offers a supportive atmosphere with excellent career growth prospects, a permanent contract, and an attractive benefits package, including private healthcare and annual bonuses.

Benefits

Annual bonus

Private healthcare

Pension

Stock purchase

Insurance

Career growth opportunities

Work-life balance

Diversity and inclusion initiatives

Qualifications

• Several years of experience in regulated environments.
• Proficient in English with strong communication skills.

Responsibilities

• Coordinate international submissions and product change notifications.
• Develop and implement programs to ensure compliance with regulations.
• Monitor regulatory changes and assess their impacts.

Skills

Regulatory Affairs

Quality Assurance

Project Management

Communication Skills

Problem Solving

Education

Bachelor’s degree in Regulatory Affairs

Bachelor’s degree in Quality Assurance

Bachelor’s degree in Engineering

Bachelor’s degree in Related Science

Tools

SAP

Job description

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Senior Regulatory Specialist (m/f/d) - IVD, Cheadle

Client: Agilent

Location: Cheadle, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 7a9e5bc9d097

Job Views: 4

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description:

Description

Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Want more information on Agilent? Check out!

We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team. You will play a key role in supporting new product introduction projects and developing regulatory strategies to bring products to the global market. Your responsibilities include coordinating international submissions, product change notifications, product release, licensing requirements, and registration of IVD products for Agilent.

The position ensures products are received, licensed, and delivered by Agilent in accordance with global regulatory and quality standards. As a member of the Global Regulatory Team, you will support international IVD registrations, including:

• Preparing documentation for regulatory submissions and listings to ensure compliance with local and regional requirements.
• Compiling materials for submissions, license renewals, and registrations. Maintaining export licenses within SAP for IVD licenses and addressing trade holds.
• Developing and implementing programs to ensure products are safe, legal, and compliant with regulations.
• Problem-solving and raising regulatory issues to senior management.
• Monitoring regulatory changes and participating in discussions to assess and communicate impacts.
• Leading regulatory projects involving coordination with Legal, Marketing, Project Management, and distributors.
• Supporting impact assessments for change controls.
• Preparing documentation for permits, licenses, and registrations.
• Consulting with regulatory agencies for guidance.
• Communicating with Channel Partners regarding registrations.

This position is preferably based in our Waldbronn office in Germany (hybrid), but can be located anywhere in Europe where Agilent has an entity.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or related science.
• Several years of relevant experience in regulated environments.
• Knowledge of international registrations.
• Teamwork skills and ability to lead and collaborate across functions and geographies.
• Experience with Quality Management Systems in the medical device industry.
• Proficient in English (written and spoken).

Preferred Qualifications

• Excellent communication, project management, and presentation skills.
• Knowledge of design controls and standards (ISO 13485, 14791).
• Experience with regulated products and knowledge of ISO standards and IVD regulations.

What We Offer

• Core global benefits, plus annual bonus, private healthcare, pension, stock purchase, and insurance (varies by country).
• Opportunities for career growth in a global company.
• Diversity and inclusion initiatives.
• Independent roles in a supportive environment.
• Exciting projects in an agile, collaborative culture.
• Work-life balance.
• Permanent contract in a growing global company.

We look forward to your application in English. Agilent is recognized as one of the best employers worldwide: Awards | Agilent Technologies